MRI/Ultrasound Fusion Guided Prostate Cryotherapy
Recruiting · NCT02381990 · Observational (researchers observe without assigning treatment) · Lead sponsor: Urological Research Network, LLC
View the official record on ClinicalTrials.gov →Interventions studied
FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY
What this trial is about
Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. The aim of intervention is to eradicate prostate cancer disease in the treated area while imposing no or minimal deleterious effects in quality of life.
Who can take part
Age range
55 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Men between 55 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and \<50% positive core rate by prostate lobe
- Men older than 65 years of age with clinical diagnosis of prostate cancer \<50% positive core rate by prostate lobe
- Absence of extra-capsular extension
- Absence of seminal vesicle invasion
- Absence of regional or distant metastatic disease
- Multiparametric MRI of the prostate performed either before the biopsy or \>10 weeks after prostate biopsy
- Treated with Cryotherapy of the prostate
- Treatment based on co-registration between MP-MRI and Prostate Ultrasound
Exclusion criteria
- Prior treatment of prostate cancer in the form of surgery.
- Performance status greater than 0 based on ECOG criteria
- Mental status impairment
Where it is running
1 location listed across 1 US state.
- Urological Research Network - Miami Lakes, Florida, United States